The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression

Exclusion Criteria

• •1. History of chronic diarrhea
• •2. Need for regular use of agents that affect gastro-intestinal (GI) motility (narcotics such as codeine or morphine, agents such as loperamide or metoclopramide)
• •3. Colostomy
• •4. Elective surgery that will require preoperative antibiotics planned within 6 months of enrolment
• •5. History of bariatric surgery.
• •6. Pregnant, breastfeeding, or planning to get pregnant in the next 6 months
• •7. Any condition for which, in the opinion of the investigator, the participant should be excluded from the study.
• •8. Current use of any antidepressant/antianxiety drug (eligible to participate after a 4-week washout period)
• •9. More than three depressive episodes throughout lifetime
• •10. Having failed an anti-depressant treatment during current depressive episode
• •11. Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period)
• •12. History of alcohol or substance dependence in the past 6 months
• •13. Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period)
• •14. Use of any type of laxative in the last 2 weeks.
• •15. Consumption of products fortified in probiotics (may be eligible to participate after a 2-week washout period)
• •16. High suicidal risk, as measured by MADRS item 10 score more than 3
• •17. Current psychotic symptoms
• •18. Bipolar Depression
• •19. History of epilepsy or uncontrolled seizures
• •20. Immunodeficiency (immuno-compromised and immuno-suppressed participants; e.g. acquired immune deficiency syndrome \[AIDS\], lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants)
• •21. Unstable medical conditions or serious diseases/conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)
• •22. The use of natural health products (NHP); e.g. St. John's Wort, passion flower, etc.) that affect depression
• •23. History of Electroconvulsive therapy (ECT)